FDA Approves First Digital Pill to Monitor When It Was Taken

The Food and Drug Administration on Monday approved the first medicine with an embedded sensor to monitor whether patients are taking their pills as prescribed. The digital pill, made by Otsuka Pharmaceutical Co. and Proteus Digital Health, is a version of Otsuka’s Abilify, which is used to treat depression, bipolar disorder, and schizophrenia. Proteus created the sensor used in the medication, and it is activated by stomach fluids to indicate when the pill has been taken. The FDA said in a press release that it “supports the development and use of new technology in prescription drugs” and that the new pill may be “useful” for treating mental illness. “This is the first time we’ll have an objective measurement of adherence,” Kabir Nath, chief executive officer for North America at Otsuka Pharmaceutical, told Bloomberg. Nath said the pill may allow doctors to prevent “dramatic and immediate health-care crises, such as for schizophrenia patients where missing medicines can result in a psychotic break which will land them in an ER.”